The present disclosure relates to apparatuses and methods for packaging a medical device. More specifically, the present disclosure relates to packages for holding a medical implant and processes for making said packages.
Conventional implant packages rely on a void-filling approach to protect their contents. The void-filling approach entails stabilizing the contents within a rigid plastic package with a variety of foams and padding materials. The foam and padding materials essentially fill the void between the implant and the inner surfaces of the rigid plastic package. The rigid plastic package is then sealed with lidstock material.
The void-filling approach requires the use of multiple foam components. These components are usually bulky and generate a considerable volume of package waste. Additionally, implants packed in foam can be difficult to remove without premature or accidental exposure to biological material on surgical gloves since the foams are intended to provide a tight fit to cushion the package and the implant. The void-filling approach also requires some manual processes, which are prone to error and typically result in a long packaging process time.
Packages filled with foam also experience problems during transportation. As a package is transported, the foam contained within the package may compress due to the repeated motion experienced during shipping. As a consequence, heavy implants packed in foam must be packed very tightly. Compressed foam allows more implant motion within the package. This implant motion may damage the implant and/or the package and negate the sterile barrier. Once the sterile barrier of a package has been compromised, the medical implant contained within that package cannot be used in surgery. What's more, if a medical implant has been contaminated and the physician has no back-up medical implant on hand, surgery could be delayed.
Foams used in void-filling packages may jeopardize the sterility of the medical implants in other ways. For instance, friction between the foam and the medical implant can abrade the foam and generate particulate. Moreover, when the medical implant is packed tightly with foam to reduce implant motion, the foam may occasionally adhere to the package lidstock during the sealing process. As a result of this improper adhesion, the foam may scorch or shear apart when the package is opened by the end user. Both of these situations may endanger the implant sterility. If the implant has been contaminated and no back-up implant is readily available, surgery could be delayed.
Although implant packages like the void-filled implants packages are well known in the art, improvements are always possible.